Remote Phase I Study Start-Up Specialist

Fortrea; Durham (NC); Remote; USD 50,000 - 70,000; Full time

Job summary

Fortrea is seeking a Study Start Up Specialist with 2+ years of start-up experience based in the U.S. The role serves as the regulatory lead for site activation and maintenance, coordinating documents for EC/IRB approvals and sponsor reviews. You will mentor teammates, navigate ICH/GCP standards, and collaborate with project teams to maintain timelines and quality across multiple countries. The position offers remote work with travel as needed.

Qualifications

• 2+ years of start-up experience or regulatory start-up work in clinical research.
• Strong working knowledge of ICH guidelines and IRB/IEC regulations.
• Experience coordinating regulatory submissions and site activation processes.

Responsibilities

• Serve as primary contact for investigative sites during start-up and maintenance.
• Coordinate collection and organization of essential documents for regulatory approvals.
• Prepare and file regulatory submissions (INDs/CTAs) and liaise with authorities.
• Ensure start-up activities comply with ICH/GCP, SOPs, and sponsor expectations.
• Mentor junior team members on start-up processes.
• Monitor timelines and flag risks to project management.

Skills

Regulatory knowledge

Clinical research

IRB/IEC processes

ICH guidelines

Education

Life science degree

Tools

Regulatory submissions software

Job description

Fortrea is seeking a Study Start Up Specialist with 2+ years of start-up experience based in the U.S. The role serves as the regulatory lead for site activation and maintenance, coordinating documents for EC/IRB approvals and sponsor reviews. You will mentor teammates, navigate ICH/GCP standards, and collaborate with project teams to maintain timelines and quality across multiple countries. The position offers remote work with travel as needed.